Cincinnati, US site management organisation (SMO) Radiant Research says that growing industry demand for trials outside the US is the key motivation for the link up with India’s Spectrum Clinical Research.
US company CardioNet, which specialises in mobile cardiac monitoring devices, has made a foray into the contract research sector with a $14m offer to acquire cardiovascular research firm Biotel.
Pfizer has become the first drugmaker to win accreditation for protecting the human rights of subjects enrolled into early-stage clinical trials under a scheme operated by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
Calls for a comprehensive reform of the system of Institutional Review Boards to protect patients in clinical trials have been voiced at a hearing of the House Subcommittee on Oversight and Investigations in the US.
Contract drug development group Systems Biology Worldwide (SBW) says the acquisition of Finnish data management specialist 4Pharma will facilitate its entry into the clinical trials sector.
UK company Paraytec has introduced a new instrument designed to allow formulation scientists to visualise – in real time – what is happening at a tablet surface when it dissolves.
The European Medicines Agency (EMEA) has called for “in-depth, prospective analysis of potential ethnic factors” when considering whether clinical trials conducted outside the EU will be acceptable in marketing authorisation applications.
Covance has expanded its clinical pharmacology capabilities via the purchase of Swiss Pharma Contract, a 50-bed clinical research company based in Basel.
The tough operating climate facing contract research organisations (CROs) seems to have hit Canada’s MDS particularly hard, with a 13 per cent drop in fiscal first quarter revenues to $257m.
UK CRO Richmond Pharmacology has unveiled a new data management offering for the drug industry that it claims will help trial sponsors cut costs, save time and help guarantee data integrity.
eClinical company etrials saw losses increase in the fourth quarter of 2008, but pointed to a healthy increase in orders as evidence of the underlying strength of the business.
PPD says it is unlikely to receive a $25m (€20m) milestone for US approval of Takeda’s diabetes drug alogliptin this year after the FDA said that cardio vascular (CV) safety data filed as part of the NDA are insufficient.
Tigermed is continuing with its plan of partnering to become the top Chinese CRO through an alliance with MacroStat to improve its range of statistical services, further broadening its business.
With M&A activity dominating Big Pharma's agenda at the moment, the contract research market is having to evolve and adapt to the turbulent environmnet. Outsourcing-pharma asked Frost & Sullivan analyst Barath Shankar to offer his opinion...
Cardiology and eClinical specialist eResearch Technology missed analysts estimates of sales and earnings in the fourth quarter of 2008, but still posted a near-14 per cent increase in operating profit.
Nose-diving net income in Q4 brought PharmaNet’s torrid year to an end, with the CRO hoping what may be its last financial release as a public company marks the start of its revival.
Synexus' new trial site in Bulgaria, which is part of the firm’s clinical research centre strategy, will help sponsors cut development times and significantly reduce costs, according to CEO Michael Fort.
Contract research firm Icon Clinical saw its revenues advance by nearly 22 per cent in the last quarter of 2008, but still saw its share price slide as investors got the jitters over the firm’s cautious predictions for 2009.
Kendle International posted a 22 per cent drop in net income to $5m, after a computer error led to problems with a clinical trial carried out for one of its customers.
Contract research and instrument company Bioanalytical Systems Inc (BASi) saw a dramatic decline in service revenues in the last quarter of 2008 on the back of its exit from the Phase I clinical trials business.
The issue of transparency in clinical research has raised its head again with a new study suggesting the results of Phase I trials are less likely to be published compared to other types of studies.
Patheon says the $183m (€142m) buy-out proposal by private equity group JLL Patheon Holdings is “opportunistic” and designed to take advantage of the recent stock-market related fluctuation in its valuation.
Study site operators want greater use of EDC technologies and more pharma industry investment to boost patient recruitment and reduce delays in clinical trials, according to an industry report due to be published next week.
Despite going through a difficult period PharmaNet is continuing to expand through the opening of another office in Latin America, which reinforces its commitment to the region.
Contract research organisation Bio-Imaging Technologies posted a 48 per cent hike on revenues in the fourth quarter of 2008, but still made a small net loss on the back of its CapMed division, which was sold last month.
Drug delivery company OctoPlus has signed a new contract with fellow Dutch company Galapagos that it says will “significantly contribute” to its revenues.
AstraZeneca has installed a customised version of Cytel’s East clinical trial design software, which the pharma giant is using to increase the efficiency and security of its clinical trials.
US software specialist etrials Worldwide has added Belgian rival Unithink to an ongoing lawsuit that accuses two former executives, Robert Sammis and Brendon Ball, of breaching confidentiality agreements.
eClinical specialist Phase Forward saw revenues top guidance with a 28 per cent increase to $48m in the fourth quarter of 2008, driven by growth in its InForm electronic data capture (EDC) system.
Pfizer has preempted the Sunshine Act by promising to disclose payments made to principal investigators, major academic institutions and research sites involved in Phase I to IV trials.
PPD has reached an agreement to buy AbCRO, which it hopes will strengthen its position in the thriving Central and Eastern European (CEE) clinical trials scene.
MDS has formed a special committee to improve shareholder value following poor results and pressure from investors to sell some of its business units, which include a CRO division.
Russia approved 615 clinical trials last year, a 9 per cent increase over 2007, lending weight to the notion that the country is becoming a global hub for clinical testing.
US company PRA International has entered into a strategic collaboration with two contract research organizations (CROs) in Southeast Asia in order to tap the fast-growing clinical research market in the region.
Parexel’s eClinical subsidiary Perceptive Informatics has entered into an alliance with AG Mednet to improve the efficiency and quality of the electronic image transfer process.
Contract research organisation PharmaNet Development Group has found a buyer just a few weeks after saying it was considering placing itself on the block.
A US federal appeal court has reinstated lawsuits by Nigerian families against Pfizer in a move that could have wide ranging implications for companies conducting clinical trials abroad.
The world’s largest contract research organisation, Covance, has maintained its earnings guidance for 2009 despite a slowdown in revenue growth and lower profits in the fourth quarter of 2008.
Icon has brought its operations in line with new FDA guidelines by implementing an electronic system to accelerate the adjudication of cardiovascular events in diabetes trials.
Contract research company Parexel saw its share rocket more than 30 per cent yesterday after it reported a hike in its second quarter revenues and despite a fallback in net profits.
The US National Institutes of Health has awarded a series of new contracts to try to stimulate greater use of sophisticated data management software in small to medium-sized clinical trials.
The US Food and Drug Administration (FDA) gave the go-ahead to the first clinical trials of a stem cell-based therapy late last week, in a major boost to the development of the technology.
Two US companies specialising in sleep disorders - Rem Medical and PsyPharma Global, have pooled their resources to offer research services to the pharmaceutical industry.
UK-headquartered Premier Research Group has signed a deal to buy the assets of fellow contract research organisation (CRO) Pivotal Research Centers, a specialist in Phase I to IIa trials, for $4.75m.
A social networking tool specifically designed for patients involved in clinical trials has been set up by Acurian, a company specialising in patient recruitment services.
An Indian doctor has slammed the nation’s clinical trials, claiming they use the vulnerable, the system is corrupt and that the country lacks high quality scientists.
The US Food and Drug Administration (FDA) has issued a draft guidance on the measures pharmaceutical and other manufacturers should take to make sure imported FDA-regulated products are in line with federal statutes and regulations.